IceCure Medical Ltd

IceCure Successfully Completes First Cryoablation Treatment in Its ChoICE Post-Marketing Study for Breast Cancer Cryoablation

IceCure Medical completed the first patient treatment in its ChoICE post-marketing study evaluating ProSense cryoablation for low-risk breast cancer. The first patient was treated at West Cancer Center & Research Institute in Germantown, Tennessee by Dr. Richard E. Fine; the study plans to enroll roughly 400 patients across up to 30 U.S. sites. Participating sites are expected to double as commercial centers, so the study supports IceCure's U.S. post-market commercial footprint for its FDA-cleared indication (patients 70+ with low-risk tumors <=1.5 cm).

•5d ago

IceCure Enrolls First Patients in Its FDA-Approved Study for ProSense® Breast Cancer Cryoablation at Two U.S. Sites

IceCure Medical enrolled the first two patients in its FDA-cleared post-marketing ChoICE Study of ProSense® cryoablation for low-risk breast cancer, at sites in Tennessee and California. The study aims to enroll roughly 400 patients across up to 30 U.S. sites, with participating centers also serving as commercial sites for ProSense®. CEO Eyal Shamir framed the enrollment as progress in the post-market strategy to generate real-world evidence and support broader clinical adoption.

•12d ago

IceCure Highlights Clinical Data and Strong Physician Engagement for ProSense® Breast Cancer Cryoablation at EUSOBI 2026

IceCure Medical's ProSense breast cancer cryoablation was featured in scientific sessions, posters and workshops at the EUSOBI 2026 Annual Scientific Meeting in Maastricht. Featured 12-month data showed objective response rates of 97.5% in 40 patients treated with cryoablation plus endocrine therapy and 91.7% in 24 patients treated with cryoablation alone. Two company-hosted workshops each drew nearly 70 participants, which management cited as evidence of growing European physician adoption of minimally invasive cryoablation.

•19d ago

IceCure Expands ProSense® ChoICE Study for Low-Risk Breast Cancer adding Legacy Health in Portland, OR as U.S. Clinical Site

IceCure Medical added Legacy Health's Good Samaritan Medical Center in Portland, Oregon as a new U.S. clinical site for its FDA-approved post-market ChoICE Study of ProSense® cryoablation in low-risk breast cancer. Dr. Nathalie Johnson, Senior Medical Director of the Legacy Cancer Institute, joins as a co-primary investigator, with Marco Aru and Jennifer Garreau serving as site co-investigators. The ChoICE Study is expected to enroll approximately 400 patients across up to 30 U.S. sites, generating real-world evidence supporting cryoablation as a minimally invasive alternative to surgery.

•26d ago

IceCure Medical Receives Regulatory Approval to Market ProSense® in China

IceCure Medical received approval from China's National Medical Products Administration for its ProSense cryoablation system and associated cryoprobes, registered as Class III medical devices. The approval enables the company's flagship system to be marketed in China under the approved registration, extending its commercial footprint beyond the U.S., Europe, and existing Asian markets. Management framed the milestone as strengthening its global regulatory position, though no launch timing, China sales partner, or revenue expectations were disclosed.

•1mo ago

IceCure Signs Exclusive Distribution Agreement for ProSense® Cryoablation Systems in the Netherlands

IceCure signed an exclusive distribution agreement with Scovas Medical to commercialize its ProSense cryoablation systems in the Netherlands for breast cancer and interventional oncology. The partnership is supported by the independent THERMAC trial, which has advanced to Phase III and reported a 94% complete ablation rate with 0% complications and 100% treatment tolerance for ProSense. CEO Eyal Shamir highlighted that the agreement strengthens the company's European commercialization strategy and expands access in a key market for minimally invasive cancer care de-escalation.

•2mo ago

West Cancer Center Receives IRB Approval to Commence IceCure's ChoICE Study for Breast Cancer Cryoablation

West Cancer Center received IRB approval to begin patient enrollment in IceCure's ChoICE post-marketing study for ProSense cryoablation. The study focuses on low-risk breast cancer patients aged 70 and older, aiming to generate real-world data across 30 participating sites and 400 patients. ProSense is the first FDA-authorized cryoablation device for this indication, supported by prior clinical data showing a 3.1% local recurrence rate.

•2mo ago

IceCure Highlights Two New Peer-Reviewed Publications Supporting Cryoablation in Breast Cancer Treatment De-Escalation

IceCure Medical highlighted two peer-reviewed publications reinforcing the role of cryoablation in breast cancer treatment de-escalation. One review cites ProSense's FDA marketing authorization and updated ASBrS guidelines, noting a favorable 3.1% Ipsilateral Breast Tumor Recurrence rate from the ICE3 trial. A second publication extends the clinical discussion to axillary lymph node metastases, potentially expanding the addressable market for curative and palliative care.

•2mo ago

IceCure Reports its Financial Results for the First Half of 2026 with 45% Revenue Growth Year-Over-Year

IceCure reported first-half 2026 revenue of $1.8 million, representing 45% year-over-year growth driven by sales of ProSense systems and disposable probes. The company expanded its active U.S. commercial install base by approximately 70% and strengthened its balance sheet to $12.0 million in cash following roughly $8.5 million in gross proceeds from financings in the second quarter. Management emphasized a self-reinforcing cycle of clinical validation and commercialization, supported by the ongoing FDA-approved CHoICE study and inclusion in key medical society guidelines.

•2mo ago

IceCure Medical Adds Adventist Health as U.S. Clinical Site for its Post-Marketing "ChoICE" Study for Low-Risk Breast Cancer Cryoablation Treatment

IceCure Medical announced Adventist Health Glendale as the first clinical site to enroll patients in its post-marketing ChoICE study for the ProSense cryoablation system. The study targets 400 patients across 30 U.S. sites to generate real-world data for low-risk breast cancer treatment in patients aged 70 and older. CEO Eyal Shamir highlighted the milestone as a step toward expanding real-world experience and access to the minimally invasive technology.

•2mo ago

IceCure: SIO Petitions NCCN to Include Cryoablation in Breast Cancer Treatment Guidelines, Citing IceCure's FDA Clearance of ProSense®

The Society of Interventional Oncology (SIO) has petitioned the National Comprehensive Cancer Network (NCCN) to include cryoablation in its Breast Cancer Guidelines, specifically citing IceCure’s FDA clearance of the ProSense system. The petition recommends a Category 2B option for patients aged 70+ and seeks to expand eligibility to patients aged 50-69 who are poor surgical candidates. Inclusion in NCCN guidelines could significantly increase clinical awareness and support future reimbursement discussions for the minimally invasive treatment.

•3mo ago

IceCure Medical Kicks Off its Post-Marketing "ChoICE" Study for the Low-Risk Breast Cancer Treatment at First U.S Clinical Site

IceCure Medical initiated its post-marketing "ChoICE" study for ProSense cryoablation in low-risk breast cancer at the first U.S. clinical site, West Cancer Center & Research Institute. The study aims to enroll up to 400 patients across 30 U.S. sites to generate real-world data supporting broader clinical adoption and access. ProSense received FDA marketing authorization in October 2025 for patients aged 70 and older with low-risk tumors.

•3mo ago

IceCure Expands U.S. Commercial Team to Meet Surging Demand for ProSense® Cryoablation

IceCure Medical is expanding its U.S. sales and marketing teams in key territories including New York, Southern California, and the Midwest to address surging demand for its ProSense cryoablation system. The expansion follows a reported 70% growth in the active U.S. commercial install base for breast cancer cryoablation, driven by FDA marketing authorization received in October 2025. Procedures are now being performed in major metropolitan areas such as Los Angeles, New York, Atlanta, and Dallas as the company scales clinical adoption.

•3mo ago

IceCure Highlights Expanding Commercial Adoption of ProSense™ Cryoablation in Brazil Following FDA Clearance for Breast Cancer

IceCure Medical reported growing commercial adoption of its ProSense system in Brazil, citing increased physician interest and procedures following recent FDA marketing authorization for early-stage breast cancer. The company highlighted ongoing independent studies, including a 750-patient trial in Brazil and a planned 900-patient study in France, led by key clinical experts to evaluate cryoablation efficacy. Executives and physicians presented clinical data at the SOBRICE Onco 2026 congress, reinforcing the technology's traction as a minimally invasive alternative to surgery in the region.

•3mo ago

IceCure Regains Compliance with Nasdaq Minimum Bid Price Requirement

IceCure Medical received notice from Nasdaq confirming it has regained compliance with the minimum bid price requirement of $1.00 per share. The determination follows a 10 consecutive business day period from June 4 to June 17, 2026, where the closing bid price met or exceeded the threshold. IceCure develops minimally invasive cryoablation technology, including its ProSense system, for treating tumors in the breast, kidney, bone, and lung.

•4mo ago

IceCure Highlights New Peer-Reviewed Journal Article in Leading Surgery Journal, Demonstrating Cryoablation's Advantages Over Radiofrequency Ablation for Early-Stage Breast Cancer

IceCure Medical highlighted a new peer-reviewed article in the International Journal of Surgery, ranked third globally, demonstrating ProSense cryoablation's clinical advantages over radiofrequency ablation for early-stage breast cancer. The publication cites data showing a 99.02% recurrence-free rate with cryoablation compared to 98.6% for RFA, while noting benefits such as the use of local anesthesia and visible ice ball margins. The company is preparing for the Japanese Breast Cancer Society meeting, and partner Terumo Corporation is expected to submit ProSense for regulatory approval in Japan in the second half of 2026.

•4mo ago

IceCure Reports 70% Growth in Active U.S. Commercial Install Base for Breast Cancer Cryoablation Following FDA Clearance

IceCure Medical reported a 70% increase in its U.S. active commercial install base for the ProSense system following FDA marketing authorization received in October 2025. The growth is driven by updated clinical guidelines from the American Society of Breast Surgeons and rising patient awareness, supported by media coverage across approximately 190 local TV stations. Management highlighted significantly higher lead generation at recent breast health conferences compared to the prior year, signaling accelerating momentum in the early stages of this commercial opportunity.

•4mo ago

IceCure Showcases ProSense® Cryoablation at American Society of Breast Surgeons 2026 Annual Meeting as Commercial Momentum Accelerates in the U.S. Market

IceCure Medical reported preliminary, unaudited estimates indicating U.S. revenue for ProSense systems and cryoprobes grew by more than 30% in the first quarter of 2026 compared to the prior year. The commercial momentum follows the recent inclusion of cryoablation in the American Society of Breast Surgeons Resource Guide as a recommended treatment for low-risk, early-stage breast cancer. At the ASBrS 2026 Annual Meeting, the company sponsored a symposium featuring Key Opinion Leaders from Cleveland Clinic and the University of Michigan who shared clinical experiences supporting the de-escalation of breast cancer care.

•5mo ago

IceCure Participates in Society of Breast Imaging Symposium 2026 as U.S. ProSense® Revenue Increases by 30%+ in First Quarter of 2026 Compared to First Quarter of 2025

IceCure expects to report that U.S. revenue for ProSense systems and cryoprobes increased more than 30% in Q1 2026 compared to the prior year, driven by adoption following the October 2025 FDA clearance. The company is expanding its installed base at leading academic hospitals and anticipates closing new system sales in Q2. Separately, a study presented at the Society of Breast Imaging Symposium showed ProSense cryoablation reduces total treatment costs by over 50% compared to breast-conserving surgery.

•6mo ago